IPHA Innate Pharma S.A.

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Innate Pharma S.A. Q2 F2026 Earnings Call Transcript

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Operator
Conference Operator
Hello, everyone. Thank you for joining us and welcome to the Innate Pharma first half 2026 business update and financial results. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star 1 again. I will now hand the conference over to Stephanie Cornen, Vice President, Investor Relations, Communication and Commercial. Stephanie, please go ahead.
Stephanie Cornen
Vice President, Investor Relations, Communication and Commercial
Good morning and good afternoon, everyone. Thank you for joining us for Innate Pharma's first half of 2026. Business Update and Financial Results Conference Call. The press release and today's presentation are both available on the IR section of our website. Before we begin, I would like to remind everyone that today's presentation includes forward-looking statements based on current expectations. These statements involve risks and uncertainties that could cause actual results to differ materially. To briefly cover today's agenda, our CEO, Jonathan Dickinson, will begin with a strategic overview and outlook. Marcus Jensen, our chief medical officer, and Yannis Morel, our chief operating officer, will then take us through updates on Lactamab, IPH4502, Monalizumab, and our preclinical ADC pipeline. Frederic Lombard, our chief financial officer, will then review our financial results. Jonathan will return for our upcoming catalysts and closing remarks before we open the call for Q&A. With that, I will now hand it over to Jonathan.
Jonathan Dickinson
Chief Executive Officer
Thank you, Stephanie. Good morning to those joining from the US and good afternoon to our European participants. Turning to slide five, the first half of 2026, together with development since the end of the period, has been marked by important progress across our focus portfolio. Starting with Lecutamab, in August, we announced our strategic partnership with Sobi to advance the program in T-cell lymphoma. As announced yesterday, that partnership is now effective following the closing of the deal. And the Telemach 3, phase 3 has been initiated. We are targeting the first patient in the study in Q1 2027 as we work toward a filing for accelerated approval in cesarean syndrome in H2 2027. For IPH 4502, as announced in July, we completed phase one dose escalation and cohort enrichment enrollment and have seen preliminary anti-tumor activity, including objective responses in post-EV urophilic cancer, as well as in non-small cell lung cancer and head and neck cancer, with a favorable safety profile observed to date. We will share initial phase one dose escalation data at the EORTC NCI AACR meeting on November 18th, 2026 in Barcelona. Turning to monolizumab, enrollment in the Pacific Nine phase three study has been completed, and we continue to expect the phase three readout in the second half of 2026. Financially, our position has been strengthened by the 75 million SOBI upfront payment associated with the closing of the deal. and the 30 million equity financial. Together, these are expected to extend our projected cash runway through the end of the first quarter of 2028. Taken together, we believe these developments position innate for several important catalysts in the second half of 2026. Let me start with Lakutamab. Lakutamab is our anti-CUR3DL2 antibody being developed in cutaneous T-cell lymphoma, or CTCL. Turning to slide seven, as I mentioned, in August, we announced a strategic partnership with SOBI to license lacutimab in T-cell lymphoma. The transaction has now closed. TELEMAC3, our confirmatory phase three study in CTCL, has been initiated. with the first patient expected in the first quarter of 2027. Innate will conduct the phase three study and we will file for accelerated approval in cesarean syndrome based on the existing phase two Telemach data. Upon the potential accelerated approval, SOBI will receive exclusive global rights to commercialize lacutamab. Following positive phase three results, Sobe will be eligible to obtain full global development rights. Under the terms of the agreement, the transaction includes a 75 million upfront payment, up to 40 million in near-term milestones connected to cesarean syndrome, and up to an additional 465 million related to Sobe's options to obtain full development rights and future regulatory and commercial milestones. The agreement also includes tiered double-digit royalties on future net sales. I'll now hand it over to Markus to review the regulatory and development path forward. Markus.
Marcus Jensen
Chief Medical Officer
Thank you, Jonathan. Liquidermap is now progressing towards phase three Thank you very much. The existing Phase 2 Telomark data are intended to support an accelerated approval filing in cesarean syndrome once Telomark 3 is underway, with the filing currently planned for the second half of 2027. As a reminder, Lacudamab has received breakthrough therapy designation from the FDA for relapsed or refractory cesarean syndrome, as well as fast track designation from from the EMA and an orphan drug status in both United States and Europe. So with the regulatory pathway established and the SOBI partnership now effective, our focus is on advancing Tillamook 3 towards first patient enrollment, first quarter 2027. Turning slide, please. I now move to ITH-A. IPH4D5 was designed to address some of the key limitations of the first generation of N4ADCs The molecule combines an exatacan topoisomerase-1 payload with our proprietary stable linker and a high-affinity Nectin-4 antibody that binds non-overlapping epitope compared with infotumab betutans. We believe these features provide an important point of differentiation as the We are now beginning to see that profile translate clinically and have observed preliminary anti-tumor activity with objective responses in heavily pre-treated patients, including patients with ulcerative cancer following prior and photo-marked pre-determined treatment, as well as in non-small cell lung cancer, head and neck cancer. The safety profile observed to date has been favorable with limited hematological toxicity. We completed dose escalation in July and are broadly tracking in line with our expectations across expansion cohorts with approximately 15 patients enrolled in both post-TB orothelial cancer, head and neck cancer, and somewhat lower enrollment in non-small cell lung cancer cohort. Data cleaning is ongoing and we look forward on November 18th, 26. Next slide, please. Our area of particular interest for IPH45 is urothelial cancer following prior EV treatment. While EV plus pembrolizumab has significantly changed the treatment landscape, most patients progress within two years, and there remains no established second-line standard treatment after progression of this regime. Against that backdrop, the preliminary activity we have observed with IPH 45.2 in heavily pre-treated post-TV patients, including objective responses, is encouraging. These remain early phase one observations, and the upcoming data set will help us to determine how to best advance the program. Slide 11, please. Slide 12, please. which is our NKG2A antibody being co-developed with AstraZeneca in non-small cell lung cancer. Specific 9 is a randomized phase 3 trial with unresectable stage 3 non-small cell lung cancer. Patients who have not progressed following a definitive platinum-based concurrent chemoradiotherapy. Study enrolled 1,051 patients in comparison to Duvalumab plus Olecumab, Duvalumab plus Monalizumab, and Duvalumab plus Placebo as a control with progression pre-survival as the primary endpoint. The program is supported by three earlier Phase II studies in non-small cell lung cancer, including COST, Neo-COST, and Neo-COST II. With enrollment complete, Phase III data and the second half of 2026. I now hand over to Yannis to briefly review the economics of our partnership with AstraZeneca.
Yannis Morel
Chief Operating Officer
Thank you, Marcus. As a reminder, under our Monalizumab partnership with AstraZeneca, we have received up to date 450 million and the additional potential milestones in the agreement are up to 825 million. together with double-digit royalties outside Europe and 50% profit sharing in Europe. Turning to slide 15, I'll move now to our next generation ADC pipeline. Beyond IPH 4502, we are using our internal capabilities and technology to build a broad portfolio of differentiated ADC candidates. Turning to slide 16, Leveraging our antibody discovery and engineering expertise, we have built a comprehensive ADC platform to develop a portfolio of next-generation ADCs designed to overcome the limitation of the current ones. Building on IPH4502 linker, which stability in patients is demonstrated by our emerging clinical data, we are developing a drug candidate portfolio around three approaches. First, Dual targeted bispecifics ADCs to address tumor antigen heterogeneity and to expand addressable indication compared to single tumor antigen targeting. Second, bispecific ADCs with enhanced internalization to unlock the activity in antigen low expressing tumors. And finally, dual payload ADCs using complementary mechanism of action to overcome resistance. I now hand over to Frederic for our financial results.
Frederic Lombard
Chief Financial Officer
Thank you, Yannis. I'll now provide a brief overview of our financial position for the first half of 2026. Turning to slide 18. So out of June 30, 2026, our cash, cash equivalent and financial assets were amounting for 21.4 million euros. That balance does not include the 75 million The primary use of proceeds is the continued clinical development of EPH 4502, the advancements of our preclinical IDC portfolio, and as well as general corporate purposes. Together with the SOBI upfront payment, these proceeds are expected to extend our cash runway through the end of the first quarter of 2028. I now hand over to Jonathan.
Jonathan Dickinson
Chief Executive Officer
Thank you, Frederic. Moving to slide 20 and turning to our key catalysts for the remainder of 2026. For Lacutimab, following closing of the strategic partnership with Sobe, Telemach 3 has been initiated with the first patient planned for the first quarter of 2027, followed by a planned filing for accelerated approval in the second half of 2027. For IPH4502, dose escalation enrollment is complete with preliminary anti-tumor activity and a favorable safety profile observed to date. We will report initial phase one dose escalation data at the EORTC NCI AACR meeting on November 18th, 2026. And for monolizumab, Pacific 9 enrollment is complete with the phase three readout expected in the second half of this year. So we have three important near-term catalysts across our focus portfolio, together with a strengthened financial position that supports our continued execution of these priorities. With that, operator, we are ready to open the call for questions.
Operator
Conference Operator
We will now begin the question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Dana Graybosch with Lerink Partners. Your line is open, Dana. Please go ahead.
Bill
Analyst, Leerink Partners
Hey, morning, everyone. So just one for me. I got Bill on for Dana. So we've seen the prior exotecan-based ADC show some pretty good activity in the post-PADSEV setting, but it did have some pretty high heme toxicities. And so can you talk about IPH45 stable linker design and sort of what gives you confidence you won't see the same sort of issues? Thank you.
Jonathan Dickinson
Chief Executive Officer
Thank you for the question. Maybe, Yannis, you can take that one.
Yannis Morel
Chief Operating Officer
Yeah, maybe I can start and let Marcus comment. We have worked on the design of the linker and based on what we have seen at ASCO, published by others with their own linker, it seems that the stability of our linker that we have seen in in preclinical models including in non-human primates seems to be translated into the human situation leading to a very limited release of a free payload which is one of the reason of the systemic pathological toxicity of some ADCs.
Marcus Jensen
Chief Medical Officer
What we can add is the Lilly data that have been released recently actually state that based on their own data that have seen in the trial. So the instable linker was used as an explanation for the hematologic toxicity in this data set.
Bill
Analyst, Leerink Partners
Thank you.
Operator
Conference Operator
Your next question comes from the line of Jeet Mukherjee with U.S. Bancorp BTIG. Your line is open, Jeet. Please go ahead.
Jeet Mukherjee
Analyst, U.S. Bancorp BTIG
Great. Good morning, and thanks for taking the question. So pending, you know, an accelerated approval there, could you speak to the potential for frontline off-label use for leucudimab and cesarean syndrome, given that seems to be the case with mogulizumab? And I have a follow-up question.
Jonathan Dickinson
Chief Executive Officer
Maybe I will take that question, so our expectation is that Lacutamab will be listed in the NCCN guidelines following the accelerated approval for both cesarean syndrome and for mycosis fungoides. I think with that listing, it seems to leave it open for physicians to be able to use the product across the different lines of therapy. Our expectation, based on the safety profile of lucutumab, which is pretty benign, we expect that you will see some off-label usage in the first-line setting. And so, yeah, I mean, I think there's an expectation you will see that. And also, despite the fact that the accelerated approval will be in cesarean syndrome, There will also be an expectation based on the potential listing in the NCCA guidelines for mycosis fungoides that you will also see usage in MF. Hopefully that answers your question.
Jeet Mukherjee
Analyst, U.S. Bancorp BTIG
Great. I appreciate that. Maybe just two other quick follow-ups. Just any initial thoughts on pricing? Do you think you could price at a premium to Mogulizumab? And then separately on Pacific Nine, in terms of just the update format, anticipate perhaps a press release at minimum from AstraZeneca, but will Innate have their own press release and analyst call as well? Thank you.
Jonathan Dickinson
Chief Executive Officer
Yeah, so in terms of pricing, we have completed pricing research in the U.S., which was conducted by ZS Associates. And what we were able to establish with U.S. payers was that we can price lacutimab between $500,000 and $625,000 per patient per annum. and that will be supported by our clinical data in the NCCN listing. So there is an expectation here that you would be able to achieve premium pricing, particularly in an indication like cesarean syndrome with a relatively low incidence, and then be able to carry that forward into the mycosis fungoides indication, which is a larger indication, but still an orphan disease. So that's pricing. And then with respect to Pacific Nine, you're correct. The expectation is that there will be a press release from AstraZeneca when the results are available. And we would also look to press release that as well and potentially do some analyst calls following the availability of that product. Primary Endpoint Data.
Jeet Mukherjee
Analyst, U.S. Bancorp BTIG
Great, thank you.
Jonathan Dickinson
Chief Executive Officer
Hopefully that answers the question.
Operator
Conference Operator
The next question will be read by Stephanie Cornen. Stephanie, please go ahead.
Stephanie Cornen
Vice President, Investor Relations, Communication and Commercial
Yes, so we have a question from Clément Stiers from Stephen. The first question is, as dose escalation and cohort expansion enrollment are now complete, Should we expect the initial ENA dataset to be primarily a safety pharmacology update or mature enough to inform subsequent development decisions?
Jonathan Dickinson
Chief Executive Officer
So Marcus, maybe you can take that question.
Marcus Jensen
Chief Medical Officer
Yeah, the question is almost the answer. This is out of 11 different indications and 76 patients. So we are expecting to see relevant and informative safety data. And we are also expecting response data from patients. And this will inform our next steps. We need to fully run the tables and we will review and disclose that as proposed on the INA meetings.
Stephanie Cornen
Vice President, Investor Relations, Communication and Commercial
Thank you, and there is another question from Clémence. With the strengthened balance sheet following the recent financing, how far along the development path could you advance IPH 4502 on your own?
Jonathan Dickinson
Chief Executive Officer
So maybe I can take that. So I think you're all aware that we did a small equity raise of 30 million euros a couple of weeks ago. The rationale behind that equity raise was to be able to progress seamlessly into the next steps for 4502. So we're well positioned now to be able to move into the next steps, whatever that will be, and the data will dictate what that is, whether it's dose optimization, and we're equipped to be able to do that. If we would need to broaden the program, if the data supports going to potentially additional tumor types, then that would require additional funding to be able to conduct multiple dose optimizations across different tumor types. But at least for the initial steps, we're funded to be able to take those steps and take the product forward seamlessly into dose optimization. Hopefully that answers the question again.
Operator
Conference Operator
We have now reached the end of the Q&A session. I will turn the call back to Jonathan Dickinson, CEO, for closing remarks.
Jonathan Dickinson
Chief Executive Officer
So thank you very much, everybody, for joining us today for our update and following our H1 results. We look forward to updating you as we progress through the important catalysts that we outlined today, which come across the remainder of the year. So thank you for your time and see you soon.
Operator
Conference Operator
This concludes today's call. Thank you for attending. You may now disconnect.